5444-0-200

GUDID 07613252133544

CMF CUSTOMIZED IMPLANT KIT MEDIUM

Howmedica Osteonics Corp.

Cranioplasty plate, non-alterable
Primary Device ID07613252133544
NIH Device Record Keyf71ae358-8b6e-4327-bcc3-d331c4847e85
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5444-0-200
Catalog Number5444-0-200
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613252133544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

Devices Manufactured by Howmedica Osteonics Corp.

07613327660180 - Instrument2026-03-09 Triathlon MS Tibial Insert Trial
07613327648386 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648393 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648409 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648416 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648423 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648430 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
07613327648447 - Instrument2026-03-06 Triathlon MS Tibial Insert Trial
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